U.S. patent number 10,939,818 [Application Number 14/479,846] was granted by the patent office on 2021-03-09 for method and device for updating medical apparatus.
This patent grant is currently assigned to LOEWENSTEIN MEDICAL TECHNOLOGY S.A.. The grantee listed for this patent is Thomas Marx, Bernd Schoeller. Invention is credited to Thomas Marx, Bernd Schoeller.
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United States Patent |
10,939,818 |
Schoeller , et al. |
March 9, 2021 |
Method and device for updating medical apparatus
Abstract
Disclosed are a method and the device for updating a ventilation
device that has a memory for an operating program. The memory is at
least partially designed as a variable memory and is connected with
an input device for a current operating program. The memory and the
input device are connected to control devices, which have testing
means for evaluating at least one code. At least one function of
the apparatus is released only when the code agrees with a
reference value.
Inventors: |
Schoeller; Bernd (Karlsruhe,
DE), Marx; Thomas (Hamburg, DE) |
Applicant: |
Name |
City |
State |
Country |
Type |
Schoeller; Bernd
Marx; Thomas |
Karlsruhe
Hamburg |
N/A
N/A |
DE
DE |
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Assignee: |
LOEWENSTEIN MEDICAL TECHNOLOGY
S.A. (Luxembourg, LU)
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Family
ID: |
1000005407882 |
Appl.
No.: |
14/479,846 |
Filed: |
September 8, 2014 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20150006196 A1 |
Jan 1, 2015 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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12148516 |
Apr 18, 2008 |
8863106 |
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Foreign Application Priority Data
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Apr 18, 2007 [DE] |
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102007018587.3 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B
5/00 (20130101); G16H 40/40 (20180101); G06F
8/65 (20130101); A61N 1/3925 (20130101) |
Current International
Class: |
A61B
5/00 (20060101); G06F 8/65 (20180101); G16H
40/40 (20180101); A61N 1/39 (20060101) |
Field of
Search: |
;717/168 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
Jamieson, "Regulation of Medical Devices involving Software in
Australia--an Overview", [Online], 2001, pp. 7-12, [Retrieved from
Internet on Oct. 24, 2020],
<https://dl.acm.org/doi/pdf/10.5555/563780.563782> (Year:
2001). cited by examiner .
Salamon et al, "Indoor Telemedicine in Hospital: a PDA-based
Flexible Solution for Wireless Monitoring and Database
Integration", [Online], 2005, pp. 386-389, [Retrieved from internet
on Oct. 24, 2020],
<https://ieeexplore.ieee.org/stamp/stamp.jsp?arnumber=1616426>
(Year: 2005). cited by examiner.
|
Primary Examiner: Sough; S.
Assistant Examiner: Wei; Zengpu
Attorney, Agent or Firm: Abel Schillinger, LLP
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
The present application is a continuation of U.S. patent
application Ser. No. 12/148,516, filed Apr. 18, 2008, the entire
disclosure of which is expressly incorporated by reference herein,
which claims priority under 35 U.S.C. .sctn. 119 of German patent
application 10 2007 018 587.3, filed Apr. 18, 2007.
Claims
What is claimed is:
1. An electronic ventilation device, wherein the ventilation device
comprises a control unit comprising (i) an internal or external
input device for data input or reception, (ii) a memory device
Which comprises one or more memories and is at least indirectly
connected with said input device, data or computing and/or counting
algorithms being stored in the one or more memories of the memory
device and testing elements automatically comparing input or
received data in the form of one or more codes with the data stored
in the one or more memories of the memory device, (iii) a control
device which, based on a comparison result provided by the testing
elements automatically causes the ventilation device to at least
temporarily be able to perform one or more functions associated
with the one or more codes only if the one or more codes are in
agreement with the data stored in the one or more memories of the
memory device, and causes performance of the one or more functions
associated with the one or more codes to be disabled by the control
device or other elements if the one or more codes are not in
agreement with the data stored in the one or more memories of the
memory device, (iv) one or more interfaces for adaptable accessory
devices, (v) one or more interfaces or modems for transmitting
recorded data to a physician and/or for transmitting other types of
recorded data to maintenance/customer service personnel, and (vi)
one or more interfaces for adapting one or more sensors for
determining one or more bodily parameters, which can be displayed
in a display of a housing of the ventilation device, one or more
areas of the display being reserved for displaying the one or more
bodily parameters and being activated only when a corresponding
sensor has been adapted, and wherein the device further comprises
hardware components which cannot work without input of a correct
code and in this respect are disabled for all functions and wherein
without input of a correct code the device or parts thereof are
prevented from being supplied with electric power or power supply
is limited in a defined way with respect to time and power.
2. The ventilation device of claim 1, wherein the ventilation
device further comprises a permanent memory which comprises
instructions that are executed after receipt or input of an update,
whereupon a rewritable memory unit is searched for updated software
and/or firmware, which is then loaded and executed.
3. The ventilation device of claim 1, wherein the ventilation
device is a stationary ventilation device.
4. The ventilation device of claim 3, wherein the ventilation
device further comprises a humidifier.
5. The ventilation device of claim 1, wherein the adaptable
accessory devices comprise a pulse oximeter.
6. The ventilation device of claim 1, wherein the adaptable
accessory devices comprise storage media.
7. A method for updating software or firmware in the electronic
ventilation device of claim 1 that comprises a rewritable memory
unit for storing an updated and/or a previous version of the
software or firmware, wherein the method comprises: (a) providing
the software or firmware for updating by an updating device; (b)
communication of the ventilation device with the updating device;
(c) when communication has been established, transmission of the
update from the updating device to the ventilation device; (d)
writing the update into the rewritable memory unit; (e)
verification of the update as a valid version and identification of
the previous version as invalid; and (f) execution of the updated
software or firmware.
8. The method of claim 7, wherein the ventilation device comprises
a microcontroller with a memory unit.
9. The method of claim 8, wherein the microcontroller is driven via
a data link as follows: (i) transmission of a signal to the
microcontroller to effect a reset of the microcontroller; (ii)
providing a flash program with new firmware for writing the new
firmware onto the microcontroller; (iii) writing a program entry
point in a defined location of the microcontroller, which is read
out first for the first time after completion of the reset.
10. The ventilation device of claim 1, wherein without input of a
correct code, one or more sensors that detect one or more
characteristic data are at least temporarily disabled.
11. The ventilation device of claim 10, wherein the one or more
characteristic data comprise one or more specific wavelengths.
12. The ventilation device of claim 1, wherein repeated input of
one or more false codes results in a temporarily limited or
unlimited disabling of acceptance of any additional codes.
13. The ventilation device of claim 12, wherein an input of a code
is re-enabled only by input of another code.
14. The ventilation device of claim 1, wherein repeated input of a
not correct update results in a temporarily limited or unlimited
disabling of acceptance of any additional update.
15. The ventilation device of claim 14, wherein input of an update
is re-enabled only by input of a correct code.
16. An electronic ventilation device, wherein the ventilation
device comprises a control unit comprising (i) an internal or
external input device for data and/or computer program input or
reception, (ii) a memory device which comprises one or more
memories and is at least indirectly connected to said input device,
data or computing and/or counting algorithms being stored in the
one or more memories of the memory device and testing elements
automatically comparing input or received data and/or computer
programs in the form of an update with the data stored in the one
or more memories of the memory device, (iii) a control device
which, based on a comparison result determined by the testing
elements, automatically causes the ventilation device to
permanently or temporarily apply the input or received data and/or
programs or data and/or programs computed therefrom to one or more
hardware functions which are associated with the update only if the
update is correct, and causes performance of one or more hardware
functions associated with the update to be disabled by the control
device or other elements if the update is not correct, (iv) one or
more interfaces for adaptable accessory devices, (v) one or more
interfaces or modems for transmitting recorded data to a physician
and/or for transmitting other types of recorded data to
maintenance/customer service personnel, and (vi) one or more
interfaces for adapting one or more sensors for determining one or
more bodily parameters, which can be displayed in a display of a
housing of the ventilation device, one or more areas of the display
being reserved for displaying the one or more bodily parameters and
being activated only when a corresponding sensor has been adapted,
and wherein the device further comprises hardware components which
cannot work without input of a correct update and in this respect
are disabled for all functions and wherein without input of a
correct update the device or parts thereof are prevented from being
supplied with electric power or power supply is limited in a
defined way with respect to time and power.
17. The ventilation device of claim 16, wherein the ventilation
device further comprises a permanent memory which comprises
instructions that are executed after receipt or input of the
update, whereupon a rewritable memory unit is searched for updated
software and/or firmware, which is then loaded and executed.
18. The ventilation device of claim 16, wherein the ventilation
device is a stationary ventilation device.
19. The ventilation device of claim 18, wherein the ventilation
device further comprises a humidifier.
20. The ventilation device of claim 16, wherein the adaptable
accessory devices comprise a pulse oximeter.
21. The ventilation device of claim 16, wherein the adaptable
accessory devices comprise storage media.
22. A method for updating software or firmware in the electronic
ventilation device of claim 16 that comprises a rewritable memory
unit for storing an updated and/or a previous version of the
software or firmware, wherein the method comprises: (a) providing
the software or firmware for updating by an updating device; (b)
communication of the ventilation device with the updating device;
(c) when communication has been established, transmission of the
update from the updating device to the ventilation device; (d)
writing the update into the rewritable memory unit; (e)
verification of the update as a valid version and identification of
the previous version as invalid; and (f) execution of the updated
software or firmware.
23. The method of claim 22, wherein the ventilation device
comprises a microcontroller with a memory unit.
24. The method of claim 23, wherein the microcontroller is driven
via a data link as follows: (i) transmission of a signal to the
microcontroller to effect a reset of the microcontroller; (ii)
providing a flash program with new firmware for writing the new
firmware onto the microcontroller; (iii) writing a program entry
point in a defined location of the microcontroller, which is read
out first for the first time after completion of the reset.
25. The ventilation device of claim 16, wherein without input of a
correct update, one or more sensors that detect one or more
characteristic data are at least temporarily disabled.
26. The ventilation device of claim 25, wherein the one or more
characteristic data comprise one or more specific wavelengths.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates to a method for updating medical apparatus,
in which an operating program stored in the apparatus is at least
partially replaced by a new operating program. The invention also
relates to a device for updating medical apparatus, said device
having a memory for an operating program.
2. Description of the Related Art
In most medical apparatus, the operating software is stored in a
permanent memory and executed by a microcontroller that is designed
for this software. Consequently, the software is stored in the form
of unalterable program instructions, and the microcontroller cannot
be upgraded and has no free capacity. In the case of software
updates, memory components must be replaced, so that it becomes
necessary for a specialist to disassemble the apparatus. A software
update of this type is complicated and expensive, because the
medical apparatus cannot be used for the duration of the update
process.
In other cases, it is necessary to replace hardware in order, for
example, to be able to use sensors with upgraded functionality.
Due to rapid ongoing technical developments, medical apparatus is
often no longer state of the art after only a short period of use.
At present, therefore, users who depend on the latest or other
required functions purchase new medical apparatus on a regular
basis.
It would be desirable to provide medical apparatus with an update
functionality that would allow the user to upgrade his medical
apparatus with the latest functions or with additional
functions.
As used in the context of the present invention, a medical
apparatus is understood to be an apparatus that is used for
medicinal, medical, or health-related purposes, especially a
measuring apparatus, diagnostic apparatus, or therapeutic
apparatus, such as a ventilator, a defibrillator, an oxygen
concentrator, a pulse oximeter, a pulse spectrometer, or a
diagnostic apparatus for respiratory disorders.
The objective of the present invention is to design a device of the
aforementioned type in such a way that the device carries out
hardware and/or software updates for a medical apparatus without it
being necessary to make a hardware replacement.
SUMMARY OF THE INVENTION
In accordance with the invention, this objective is achieved by
virtue of the fact that the memory is at least partially designed
as a variable memory and is connected with an input device for a
current operating program and that the memory and the input device
are connected to control devices, which have testing means for
evaluating at least one code, where at least one function of the
apparatus is released only when the code agrees with a reference
value.
In particular, in accordance with the invention, the objective is
achieved by virtue of the fact that the device of the invention for
a medical apparatus consists of an internal or external input
device for data input and/or data reception and of a memory device
that is at least indirectly connected with said input device, with
data or computing and/or counting algorithms stored in at least one
memory in the memory device and with testing means that
automatically compare the input or received data (here: "code")
with data stored in one or more memories of the memory device,
including especially after or while the code and/or the data stored
in one or more memories were or are being processed (especially
were or are passing through computing and/or counting algorithms),
where control devices are present, which, on the basis of the
comparison result determined by the testing means and only in the
case of a certain well-defined code or certain well-defined codes,
automatically cause the apparatus at least temporarily to be able
to perform certain functions associated with these codes and cause
the performance of these functions associated with the codes to be
disabled by these control devices or by other means without the
proper code.
A further objective of the invention is to improve a method of the
aforementioned type in a way that is conducive to simple updating
of the apparatus.
In accordance with the invention, this objective is achieved by
virtue of the fact that the operating program is at least partially
stored in a variable memory of the apparatus and during the
performance of the update is at least partially replaced by the new
operating program.
In accordance with one embodiment of the invention, the device for
a medical apparatus consists of an internal or external input
device for data inputs and/or computer program inputs or for data
reception and/or computer program reception and of a memory device
that is at least indirectly connected with said input device, with
data or computing and/or counting algorithms stored in one or more
memories in the memory device and with testing means that
automatically compare the input or received data and/or computer
programs, referred to here as "updates", with data stored in one or
more memories of the memory device, including especially after or
while the update and/or the data stored in one or more memories
were or are being processed and especially were or are passing
through computing and/or counting algorithms, where control devices
are present, which, on the basis of the comparison result
determined by the testing means and only in the case of certain
well-defined updates, automatically cause the apparatus permanently
or temporarily to apply these data, programs, or data or programs
computed from them to hardware functions that are associated with
these updates and cause the performance of these hardware functions
associated with the updates to be disabled by these control devices
or by other means without the proper update.
In the context of the invention, operating programs are, for
example, the operating software for the operation of the apparatus,
application programs, evaluation programs for measured values, or a
communication program.
In accordance with another embodiment of the invention, the device
for a medical apparatus consists of an internal or external input
device for data inputs or data reception and of a memory device
that is at least indirectly connected with said input device, with
data or computing and/or counting algorithms stored in one or more
memories in the memory device and with testing means that
automatically compare the input or received data, here: "code",
with data stored in one or more memories of the memory device,
including especially after or while the code and/or the data stored
in one or more memories were or are being processed, where control
devices are present, which, on the basis of the comparison result
determined by the testing means and only in the case of a certain
well-defined code or certain well-defined codes, automatically
cause the apparatus to cooperate permanently or temporarily with
one or more specific additional internal or external hardware
components that are associated with these codes and cause the
cooperation of the apparatus with a hardware component associated
with the codes to be disabled by these control devices or by other
means without the proper code.
Functionality that is optimized for the user is achieved by
notifying the user of a positive comparison result by an acoustic,
optical or other type of display or signal, e.g., as a success
message or signal.
Functionality that is optimized for the user is also achieved by
notifying the user of a negative comparison result by an acoustic,
optical or other type of display or signal, e.g., as an error
message or fault signal.
Expanded functionality is realized by storing in the memory device
and/or in the code data which, even in processed or computed form,
temporarily limit the execution of the functions and/or the
disabling of the functions in a well-defined way.
An individually adaptable application is realized if the apparatus
contains hardware components that cannot work without the input of
the code and in this respect are disabled for all functions.
An embodiment of the invention with a simple design is realized if
the apparatus or parts of it are prevented from being supplied with
electric power (e.g., by mains connection, batteries, or secondary
cells) without the code input, or the supply is limited in a
well-defined way with respect to time or power.
Fast realization of the release is achieved if the code is input or
transmitted to the input device by means of a data carrier with
patient-related, practice-related, or physician-related data, such
as the health card, or by a reading device designed for this
purpose.
Effective disabling is realized by disabling certain components of
the apparatus, especially sensors that detect certain
characteristic data, so that they are at least temporarily disabled
for use by the apparatus without the input of the code.
Expanded functionality is produced by storing in the memory device
and/or in the code data which, even in processed or computed form,
temporarily limit the execution of the hardware functions and/or
the disabling of the hardware functions in a well-defined way.
An embodiment of the invention with a simple design is realized if
the apparatus contains hardware components that cannot work without
the update of the code and in this respect are disabled for all
functions.
In accordance with the invention, certain components of the
apparatus, especially sensors that detect certain characteristic
data, such as wavelengths, are at least temporarily disabled for
use by the apparatus without the update.
In accordance with the invention, data which temporarily limit the
cooperation of the apparatus with the associated additional
hardware component and/or its disabling are stored in the memory
device and/or in the code.
In accordance with the invention, alternatively and/or
additionally, the apparatus already contains hardware or software
components that cannot work without the cooperation of the
apparatus with the associated additional hardware component and in
this respect are already disabled for all functions.
An embodiment of the invention with respect to the apparatus is
realized if the hardware components that are already present and
are disabled without the code and/or the additional hardware
components are well-defined sensors, especially of a specific
wavelength.
In a variant with a simple design, the code is stored in the
additional hardware component and/or in the means which connect the
additional hardware component with the apparatus and reaches the
input device by the creation of the connection between this
hardware component and the apparatus.
Increased functionality is produced if an optical or acoustic or
mechanical display/signal output is present that keeps
display/output possibilities ready for release by code, the upgrade
or the additional hardware component, which display/output
possibilities cannot be used without their release by code, the
upgrade, or the additional hardware component.
Protection from improper use is realized if a well-defined repeated
input of one or more false codes or one or more improper updates
leads to temporarily limited or unlimited disabling of the
acceptance of any additional input for codes or updates, which
possibly can be reenabled only with another code (which, for
example, is known only by the manufacturer).
In accordance with one embodiment, the invention can be realized as
a method for updating software and/or firmware in electronic
medical apparatus, where the medical apparatus has a rewritable
memory unit for storing an updated and/or a previous version of the
software and/or firmware, said method comprising the following
steps:
(a) preparation of the software and/or firmware for updating by
means of an updating device;
(b) communication of the medical apparatus with the updating
device;
(c) when communication has been established: transmission of the
update from the updating device to the medical apparatus;
(d) writing the update into a rewritable memory unit;
(e) verification of the update as a valid version and
identification of the previous version as invalid; and
(f) execution of the updated software and/or firmware.
In accordance with the invention, it is contemplated that the
previous version is overwritten with the updated software and/or
firmware or is moved to a restore memory, especially if the updated
form is released only for a limited time.
In accordance with the invention, it is also contemplated that the
medical apparatus additionally contains a permanent memory,
including instructions that are executed after the update,
whereupon the rewritable memory unit is searched for updated
software and/or firmware, which is then loaded and executed.
In accordance with another embodiment, the invention can be
realized as a method for updating software and/or firmware in
electronic medical apparatus, where the medical apparatus has a
microcontroller with a memory unit, and the microcontroller can be
driven as follows via a data link, for example, via free PIN's:
(a) transmission of a signal to the microcontroller to effect a
reset of the microcontroller, for example, via free PIN's;
(b) preparation of a flash program with new firmware for writing
the new firmware onto the microcontroller,
(c) where the program entry point is written in a well-defined
location of the microcontroller, which is read out for the first
time after completion of the reset.
BRIEF DESCRIPTION OF THE DRAWINGS
Specific embodiments of the invention are schematically illustrated
in the drawings.
FIG. 1 shows a perspective view of a ventilator with a connecting
hose running to a ventilation mask.
DETAILED DESCRIPTION OF THE INVENTION
FIG. 1 shows the basic design of a ventilation device. The housing
1 of the apparatus has an operating panel 2 and a display 3, and a
respiratory gas pump is installed inside the apparatus housing 1. A
connecting hose 5 is attached by a coupling 4. An additional
pressure-measuring hose 6, which can be connected with the
apparatus housing 1 by a pressure input connection 7, can run along
the connecting hose 5. To allow data transmission, the apparatus
housing 1 has an interface 8. Other pieces of medical apparatus can
be connected via this interface 8. For example, a pulse oximeter or
a pulse spectrometer can be connected. A humidifier can also be
adapted.
An expiratory element 9 is installed in an expanded area of the
connecting hose 5 that faces away from the apparatus housing 1. An
expiratory valve can also be used.
FIG. 1 also shows a patient interface in the form of a ventilator
mask 10, which is designed as a nasal mask. The mask can be
fastened on the patient's head by a headgear 11. The expanded area
of the patient interface 10 that faces the connecting hose 5 has a
coupling device 12.
Data can be input and/or output via the interface 8, for example,
the dead space volume or a software update or firmware update can
be input. The interfaces can be realized in cable-connected form,
as infrared interfaces, Bluetooth interfaces, or USB. An oxygen
supply valve can be adapted to the ventilator in the area of the
apparatus housing. It is also possible to provide additional oxygen
enrichment of the respiratory gas in order to improve the oxygen
supply to the patient.
In addition, the apparatus can be provided with interfaces for
adaptable accessory devices and information management systems, for
example, for accepting storage media or for connecting to an EKG,
EEG, printer, defibrillator, pulse oximeter, or other medical
apparatus.
It is also possible to use a modem or other interface to transmit
recorded data to the physician, such as trends, unusual events,
warning messages, etc., and to transmit other types of recorded
data to the user or to maintenance/customer service personnel, such
as peculiarities, operating hours, or other types of information
that are useful for ensuring perfect operation.
It is also possible to use an interface to adapt sensors for
determining other bodily parameters. For example, adaptable
accessory devices, such as an EKG, EEG, EOG, pulse oximeter, and
pulse spectrometer, can be added on. The bodily parameters
determined by the adapted sensors can be displayed on the
ventilator display. Certain areas of the display are reserved for
this purpose and are activated only when the given sensor has been
adapted. Measured values determined by the given adapted sensors
are then displayed in these display areas.
In another embodiment, the device of the invention is realized for
a pulse oximeter, which determines oxygen saturation SpO2 by means
of at least two wavelengths. In addition, the pulse oximeter has an
additional wavelength that can be used for the determination of
other parameters, such as methemoglobin or carboxyhemoglobin. This
additional function is not released for use in the current
configuration of the pulse oximeter, but rather a code must be
input to release this function and/or an expanded computing and/or
counting algorithm must be installed. The device consists of an
input device for data input/data reception, especially for
receiving updates or upgrades of the computing and/or counting
algorithms of the pulse oximeter, and of a memory device connected
with the input device, with computing and/or counting algorithms
stored in at least one memory, which algorithms serve the purpose
of determining at least the following test parameters: SpO2 and
pulse rate.
A code that serves to release the apparatus functions can be input
through the input device for data input/data reception, which is
realized, for example, as a keyboard.
Testing means compare the input code with a comparison code stored
in a memory of the memory device for the purpose of verifying the
code, where control devices, on the basis of the comparison result
determined by the testing means and only in the case of a certain
well-defined code or certain well-defined codes, automatically
cause the pulse oximeter at least temporarily to be able to perform
certain functions, namely, the determination of the expanded test
quantities (e.g., methemoglobin or carboxyhemoglobin) with the use
of at least three wavelengths associated with these codes. The
execution of these functions associated with the codes is disabled
by the control devices or by other means without the proper
code.
After the code has been input, the user is notified of a positive
comparison result by receiving an acoustic or optical success
message, for example, in the form of an LED that shines green.
The user is notified of a negative comparison result by receiving
an acoustic or optical error message, for example, in the form of
an LED that shines red.
In accordance with the invention, the sensor of the pulse oximeter
is already equipped for the determination of additional test
parameters, such as methemoglobin and/or carboxyhemoglobin and/or
hemoglobin concentration, for example, by virtue of its ability to
emit at least three different wavelengths. Two of these wavelengths
are used for the determination of SpO2. A code is input to activate
at least one additional wavelength, for example, by operating the
respective LED of, say, the power supply and evaluating the data of
at least three different wavelengths according to a computing
and/or counting algorithm to determine the SpO2 and the other test
parameters, such as methemoglobin and/or carboxyhemoglobin and/or
hemoglobin concentration.
In a preferred embodiment, the supplying of additional LED's with
electric power is prevented without the code input.
In another embodiment, the device of the invention is realized for
a pulse oximeter that has at least three wavelengths in the range
of 500 nm to 950 nm, which are used to determine the parameters of
methemoglobin or carboxyhemoglobin and SpO2 and pulse rate. In
addition, the sensor of the pulse oximeter has at least one
additional wavelength in the range of 950 to 2,500 nm, which can be
used to determine the hemoglobin concentration cHb, where this
function is not released in the current configuration of the pulse
oximeter.
To release the additional wavelength in the range of 950 to 2,500
nm, which is used for determining the hemoglobin concentration, a
code must be input. The code releases the corresponding LED and/or
an expanded computing and/or counting algorithm, specifically, to
allow the determination of the cHb from at least four wavelengths
in the range of 500 to 2,500 nm.
In another embodiment, the device of the invention is realized for
a pulse oximeter that has at least three wavelengths in the range
of 500 nm to 950 nm, which are used to determine the parameters of
methemoglobin or carboxyhemoglobin and SpO2 and pulse rate. In
addition, the sensor of the pulse oximeter has at least one
additional wavelength in the range of 950 to 2,500 nm, which can be
used to determine the hemoglobin concentration cHb. To determine,
for example, the hemoglobin concentration, an expanded computing
and/or counting algorithm is installed via the input device for
data input/data reception and stored in a memory in the memory
device connected with the input device, where the program entry
point of the expanded computing and/or counting algorithm is
written in a well-defined memory location, which is read out for
the first time.
The computing and/or counting algorithm that was previously used to
determine the parameters methemoglobin or carboxyhemoglobin and
SpO2 and pulse rate is preferably overwritten or deactivated.
In a supplementary embodiment, the device of the invention for a
pulse oximeter consists of an input device for an update and of a
memory device that is connected with the input device, with a
computing and/or counting algorithm stored in a memory in the
memory device, said algorithm serving to determine the parameters
SpO2 and methemoglobin and/or carboxyhemoglobin with the use of the
data of at least three wavelengths in the range of 500 to 950 nm,
where testing means automatically compare the update with data
stored in the memories of the memory device, and a control device,
on the basis of the comparison result determined by the testing
means and only in the case of verification of the update, causes
the pulse oximeter to execute the update, where the update serves
to determine the parameter hemoglobin concentration with the use of
the data of at least four wavelengths in the range of 500 to 2,500
nm.
Alternatively, the device can be realized for a pulse oximeter that
is used for determining the parameters SpO2 and pulse rate. To this
end, the pulse oximeter uses a sensor with two active LED's that
are used for determining SpO2. In addition, the sensor has at least
one LED that is not active but can be activated and that serves the
purpose of determining at least one additional parameter (selected
from the following group: methemoglobin, carboxyhemoglobin,
hemoglobin concentration, bilirubin, glucose).
The pulse oximeter has a computing and/or counting algorithm that
is used to determine SpO2 and pulse rate. In addition, it can
determine at least one other parameter (selected from the following
group: methemoglobin, carboxyhemoglobin, hemoglobin concentration,
bilirubin, glucose). The pulse oximeter also has an input device
for data input and testing means connected with said input device
4.
To activate the unused LED and/or the computing and/or counting
algorithm for the additional determination of at least one other
parameter (selected from the following group: methemoglobin,
carboxyhemoglobin, hemoglobin concentration, bilirubin, glucose), a
code is input via the input device for data input and compared by
the testing means with the data stored in a memory of the memory
device. On the basis of the comparison result determined by the
testing means, a control device causes the activation of the unused
LED and/or the computing and/or counting algorithm for the
additional determination of at least one other parameter (selected
from the following group: methemoglobin, carboxyhemoglobin,
hemoglobin concentration, bilirubin, glucose), if the input code
has been verified by the testing means.
In another embodiment, the pulse oximeter has a display that keeps
display/output possibilities ready for release only after release
by a code or after an upgrade has been carried out. Thus, during
the operation of the apparatus, before the update is performed, for
example, the parameters SpO2 and pulse rate are displayed. After
the update has been performed, the display/output is activated in
the display area to display the parameters methemoglobin and/or
carboxyhemoglobin and/or hemoglobin concentration and/or bilirubin
and/or glucose, for example in the form: SaMet, SaCO, SaO2, cHb,
where cHb and glucose are displayed in g/dL, and, for example,
SaMet and SaCO are displayed in %. These are only some of the
possible applications, which can also apply to other
parameters.
For example, the display range for the concentration of hemoglobin
cHb is 5 to 25 g/dL. Alternatively or additionally, a display in
mmol/L may be provided. The display range for a carbon monoxide
fraction in the blood is 0% to 60%.
In accordance with the invention, it is also possible to perform an
update for the determination of the parameter bilirubin. In
accordance with the invention, the update is carried out starting
from at least two different wavelengths selected from the group
comprising 300 nm.+-.15%, 400 nm.+-.15%, 460 nm.+-.15%, 480
nm.+-.15%, 520 nm.+-.15%, 550 nm.+-.15%, 560 nm.+-.15%, 606
nm.+-.15%, 617 nm.+-.15%, 620 nm.+-.15%, 630 nm.+-.15%, 650
nm.+-.15%, 660 nm.+-.15%, 705 nm.+-.15%, 710 nm.+-.15%, 720
nm.+-.15%, 805 nm.+-.15%, 810 nm.+-.15%, 880 nm.+-.15%, 905
nm.+-.15%, 910 nm.+-.15%, 950 nm.+-.15%, 980 nm.+-.15%, 980
nm.+-.15%, 1,050 nm.+-.15%, 1,200 nm.+-.15%, 1,310 nm.+-.15%, 1,380
nm.+-.15%, 1,450 nm.+-.15%, 1,600 nm.+-.15%, 1,800 nm.+-.15%, 2,000
nm.+-.15%, 2,500 nm.+-.15%, and expanding to at least three
different wavelengths selected from the group comprising 300
nm.+-.15%, 400 nm.+-.15%, 460 nm.+-.15%, 480 nm.+-.15%, 520
nm.+-.15%, 550 nm.+-.15%, 560 nm.+-.15%, 606 nm.+-.15%, 617
nm.+-.15%, 620 nm.+-.15%, 630 nm.+-.15%, 650 nm.+-.15%, 660
nm.+-.15%, 705 nm.+-.15%, 710 nm.+-.15%, 720 nm.+-.15%, 805
nm.+-.15%, 810 nm.+-.15%, 880 nm.+-.15%, 905 nm.+-.15%, 910
nm.+-.15%, 950 nm.+-.15%, 980 nm.+-.15%, 980 nm.+-.15%, 1,050
nm.+-.15%, 1,200 nm.+-.15%, 1,310 nm.+-.15%, 1,380 nm.+-.15%, 1,450
nm.+-.15%, 1,600 nm.+-.15%, 1,800 nm.+-.15%, 2,000 nm.+-.15%, 2,500
nm.+-.15%.
In accordance with the invention, it is also conceivable, starting
from at least two wavelengths, to expand to at least four
wavelengths via an update, with the four wavelengths being selected
from the group comprising 300 nm.+-.15%, 400 nm.+-.15%, 460
nm.+-.15%, 480 nm.+-.15%, 520 nm.+-.15%, 550 nm.+-.15%, 560
nm.+-.15%, 606 nm.+-.15%, 617 nm.+-.15%, 620 nm.+-.15%, 630
nm.+-.15%, 650 nm.+-.15%, 660 nm.+-.15%, 705 nm.+-.15%, 710
nm.+-.15%, 720 nm.+-.15%, 805 nm.+-.15%, 810 nm.+-.15%, 880
nm.+-.15%, 905 nm.+-.15%, 910 nm.+-.15%, 950 nm.+-.15%, 980
nm.+-.15%, 980 nm.+-.15%, 1,050 nm.+-.15%, 1,200 nm.+-.15%, 1,310
nm.+-.15%, 1,380 nm.+-.15%, 1,450 nm.+-.15%, 1,600 nm.+-.15%, 1,800
nm.+-.15%, 2,000 nm.+-.15%, 2,500 nm.+-.15%.
To determine the hemoglobin concentration cHb, the invention
provides, for example, that, starting from at least two
wavelengths, the number of wavelengths is expanded to at least
three via an update, such that there is high absorption for water
at least at one wavelength selected from the group comprising 950
nm.+-.15%, 980 nm.+-.15%, 980 nm.+-.15%, 1,050 nm.+-.15%, 1,200
nm.+-.15%, 1,310 nm.+-.15%, 1,380 nm.+-.15%, 1,400 nm.+-.15%, 1,450
nm.+-.15%, 1,500 nm.+-.15%, 1,550 nm.+-.15%, 1,600 nm.+-.15%, 1,700
nm.+-.15%, 1,800 nm.+-.15%, 1,900 nm.+-.15%, 2,000 nm.+-.15%, 2,500
nm.+-.15%.
In accordance with the invention, it is also possible to connect an
apparatus that is used for medicinal, medical, or health-related
purposes, especially a measuring apparatus, diagnostic apparatus or
therapeutic apparatus, at least temporarily with an adaptable
accessory device, for example, an EKG, EEG, EOG, printer, monitor,
defibrillator, pulse oximeter or other medical apparatus. In this
case, it is also provided that the adaptable accessory device be
released by a code input.
* * * * *
References